Atropine-effect During Propofol/Remifentanil Induction

Evaluation of the Effects of the Addition of Atropine During Propofol/Remifentanil Induction of Anesthesia on Hemodynamics, Microvascular Blood Flow and Tissue Oxygenenation in Patients Undergoing Ophthalmic Surgery

Remifentanil is a widely used potent intravenous opioid with the advantage of having a short time of action. Compared to other opiates however remifentanil generates more intense hemodynamic side-effects. In ophthalmic surgery the specific anesthesiological challenges necessitate the administration of a combination of relatively high doses of analgesics on the one hand and a short time for postoperative recovery from anesthesia on the other. For these reasons, anesthetic management often consists of a combination of relatively high doses of propofol and remifentanil. A primary concern during this deep propofol/remifentanil anesthesia is preserving hemodynamic stability and adequate tissue oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on hemodynamics as well as on tissue oxygenation. Therefore, the investigators hypothesize that administration of intravenous atropine during induction of propofol/remifentanil may have a positive effect on the hemodynamic profile and peripheral and cerebral tissue oxygenation during and after induction of anesthesia.

Study Overview

• Status: Completed
• Conditions: Anesthesia-induced Negative Hemodynamic Effects
• Intervention / Treatment: Drug: Placebo; Drug: Atropine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients requiring general anaesthesia;
• Patient's age ≥ 18 years and older;
• Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.

Exclusion Criteria:

• Patient's refusal;
• Pregnancy;
• Patient's age < 18 years;
• Patients in which atropine is contra-indicated, such as severe aortic valve stenosis, hypertrophic cardiomyopathy or coronary artery disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: General anesthesia + placebo; Propofol/remifentanil anesthesia + saline	Drug: Placebo; Saline; Other Names: Saline
Active Comparator: General anesthesia + atropine; Propofol/remifentanil anesthesia + atropine	Drug: Atropine; Atropine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiac output	During anesthesia
Peripheral tissue oxygen saturation	During anesthesia
Cerebral tissue oxygen saturation	During anesthesia

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart rate	During anesthesia
Mean arterial blood pressure	During anesthesia
Systemic vascular resistance	During anesthesia

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Alain F Kalmar, MD, PhD, University Medical Center Groningen

Publications and helpful links

General Publications

• Poterman M, Scheeren TWL, van der Velde MI, Buisman PL, Allaert S, Struys MMRF, Kalmar AF. Prophylactic atropine administration attenuates the negative haemodynamic effects of induction of anaesthesia with propofol and high-dose remifentanil: A randomised controlled trial. Eur J Anaesthesiol. 2017 Oct;34(10):695-701. doi: 10.1097/EJA.0000000000000639.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimated): June 7, 2013

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: Retro-002